Market Report Source

Overview

Introduction

Patients in a clinical population receive drug and non-drug therapy for female sexual dysfunction, yet a third remain refractory to treatment, highlighting a need for a formally approved product for FSD. There is a low level of satisfaction with the classification guidelines, further limiting diagnosis, already hampered by embarrassment, lack of physician awareness and an unclear referral system.

Scope

• Review of the disease definition, classification and key patient segmentation for female sexual dysfunction
• Assessment of the current unmet needs in the treatment of female sexual dysfunction
• Exploration of the screening, presentation and referral patterns within the female sexual dysfunction population in the 5EU and US
• Prescription and treatment trends among important subcategories of female sexual dysfunction, such as hypoactive sexual desire disorder (HSDD)

Highlights

Testosterone therapies are already widely used among women with hypoactive sexual desire disorder and female sexual arousal disorder. There is a significant market for a formally approved testosterone product for women, with 85% of prescribers willing to switch existing testosterone users onto an approved product. There is a distinct need for more specialized services in support of those with sexual functioning problems. There is no clear referral pathway for primary care physicians and no specialist service for patients to present directly to. This causes a barrier to presentation, diagnosis and treatment. The identification and classification of FSD is biased by physician’s perception. A woman presenting with sexual difficulties could receive a variety of diagnoses or even no diagnosis at all. There is a need not only for a more holistic approach to sexual dysfunction, but also for validated and consistent tools to assess and diagnose patients.

Reasons to Purchase

• Understand key opinion leaders views on topical issues in the female sexual dysfunction market
• View quantified, pictorial treatment pathways of female sexual dysfunction patients in the UK, US and Spain
• Examine treatment trends for female sexual dysfunction subtypes, hypoactive sexual desire disorder and female sexual arousal disorder

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Women’s Health pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the FSD market

There is a low level of satisfaction with currently available classification diagnostic guidelines for FSD

Presentation by women with sexual functioning problems is limited by a number of factors including ‘embarrassment’, lack of physician awareness and education and a need for a referral process/direct access to specialists

There is both space and a significant unmet need for a formally approved product or products for female sexual dysfunction

CHAPTER 2 INTRODUCTION AND SCOPE

Scope and objectives

Breakdown of the Stakeholder Opinions Survey

Limitations

CHAPTER 3 COUNTRY TREATMENT TREES

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

Introduction

Theories of female sexual response

Masters and Johnson’s linear model

Kaplan’s revision

Criticisms of early models

Circular model: Whipple and Brash-McGreer after Reed

Basson’s non-linear model

Disease definition and classification

Classifications and diagnostic criteria of FSD

ICD-10

DSM-IV

AFUD

Limitations of classifications

Epidemiology of FSD from secondary published research

Inherent difficulties in assessing prevalence of FSD

Country-specific epidemiological estimates

US National Health and Social Life Survey: widely quoted but open to criticism

FSD increases with age in Japanese women

FSD highly prevalent in young German women

FSD extensively studied in UK

The Global Study of Sexual Attitudes and Behaviors

Epidemiology of FSD according to Datamonitor’s physician survey

FSD subtypes

Sexual pain disorder

Niche populations and co-morbid conditions

Partners with erectile dysfunction

Depression and antidepressants

Cardiovascular disease

Diabetes

Postpartum

Unmet need in FSD

Need for improved tools for assessment and diagnosis

Need for objective measures for FSD

Need for an approved therapy for FSD

Need for investment in supporting services and clear referral pathway

Need for physician education

CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS

Presentation and diagnosis

Presentation and referral patterns

Help-seeking behavior and barriers to presentation

Let’s talk about sex…or not.

Sexual dysfunction as a primary versus secondary complaint

Top 10 symptoms and complaints reported at initial presentation

Screening practices

Who to screen?

Diagnosis, guidelines and satisfaction with classification systems

Guidelines for diagnosis

How useful are FSD diagnostic guidelines in clinical practice?

CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS

Treatment options

Physicians responsible for the treatment of FSD

Treatment rates

Non-drug therapy options

The importance of counseling

Counseling and therapy most prevalent in US

Fewer non-drug options in UK

Devices and lubricants favored over education in Spain

FDA-approved devices

Hypoactive sexual desire disorder

Therapeutic approach – drug versus non-drug treatment

Drug treatment – monotherapy versus combinations

HSDD drug treatment breakdown

Female sexual arousal disorder

Therapeutic approach – drug versus non-drug treatment

Drug treatment – monotherapy versus combinations

FSAD drug treatment breakdown

BIBLIOGRAPHY

APPENDIX A

Physician research methodology

Physician sample breakdown

US

France

Germany

Italy

Spain

UK

Contributing experts

APPENDIX B

THE SURVEY QUESTIONNAIRE

1. EPIDEMIOLOGY

2. SCREENING AND DIAGNOSIS

3. TREATMENT PRACTICES

3.1 General treatment approach to female sexual dysfunction

3.2. Case study – Hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD)

3.3 Testosterone therapy for low libido (hypoactive sexual desire disorder)

Disclaimer

List of Tables

Table 1: Prevalence of sexual dysfunction and help-seeking behavior in the US – NHSLS data (%), 1999

Table 2: US prevalence of FSD based on NHSLS data, 2005

Table 3: UK prevalence of FSD by subtype in women aged 18-75 years

Table 4: GSSAB prevalence of female sexual problems by region (%), 2005

Table 5: Prevalence of low desire in women aged 40-80 years based on GSSAB data, 2005

Table 6: Prevalence of lack of orgasm in women aged 40-80 years based on GSSAB data, 2005

Table 7: Prevalence of sexual pain in women aged 40-80 years based on GSSAB data, 2005

Table 8: Prevalence of arousal problems in women aged 40-80 years based on GSSAB data, 2005

Table 9: Percentage of premenopausal patients experiencing each sexual dysfunction subtype in the US, UK, Spain and Germany/Italy/France, 2005

Table 10: Percentage of postmenopausal patients experiencing each sexual dysfunction subtype in the US, UK, Spain and Germany/Italy/France, 2005

Table 11: Estimated proportion of patients with sexual functioning problems with co-morbid conditions and potential risk factors in the US, UK and Spain (%), 2005

Table 12: Percentage of pre- and post-menopausal women presenting directly and being referred to respondents for their sexual functioning problems by country, 2005

Table 13: Percentage of pre- and post-menopausal women presenting directly and being referred to respondents for their sexual functioning problems by respondent type in the US , UK, Spain and Germany/Italy/France, 2005

Table 14: Top 10 factors cited by respondents as preventing women who are experiencing sexual problems from seeking help in the US , UK, Spain and Germany/Italy/France, 2005

Table 15: Percentage of premenopausal and postmenopausal patients experiencing sexual dysfunction as a primary versus secondary complaint by country, 2005

Table 16: Percentage of premenopausal and postmenopausal patients experiencing sexual dysfunction as a primary versus secondary complaint by respondent type in the US , UK, Spain and Germany/Italy/France, 2005

Table 17: Percentage of respondents reporting the most common complaints with sexual functioning at presentation by country, 2005

Table 18: Respondent satisfaction with current FSD classification systems by region, 2005

Table 19: Physician specialties responsible for the treatment of FSD in sampled countries in the US, UK, Spain and Germany/Italy/ France, 2005

Table 20: Percentage of patients with FSD receiving each treatment approach by country and region, 2005

Table 21: Breakdown of treatment received by premenopausal patients with HSDD by region (%), 2005

Table 22: Breakdown of treatment received by postmenopausal women with HSDD by region (%), 2005

Table 23: Percentage of premenopausal and postmenopausal HSDD patients receiving mono or combination prescription drug therapy by region, 2005

Table 24: Premenopausal HSDD drug treatment by drug class in the US , UK, Spain and Germany/Italy/France (%), 2005

Table 25: Breakdown of drug prescribing in the premenopausal HSDD population by country and region (%), 2005

Table 26: Percentage of postmenopausal HSDD patients receiving each drug therapy option by country and region, 2005

Table 27: Breakdown of treatment received by premenopausal patients with FSAD by country (%), 2005

Table 28: Breakdown of treatment received by postmenopausal patients with FSAD by country (%), 2005

Table 29: Percentage of premenopausal and postmenopausal FSAD patients receiving mono or combination prescription drug therapy by region, 2005

Table 30: Percentage of premenopausal FSAD patients receiving each drug therapy option by country and region, 2005

Table 31: Percentage of postmenopausal FSAD patients receiving each drug therapy option by country and region, 2005

Table 32: US physician sample breakdown, 2005

Table 33: France physician sample breakdown, 2005

Table 34: Germany physician sample breakdown, 2005

Table 35: Italy physician sample breakdown, 2005

Table 36: Spain physician sample breakdown, 2005

Table 37: UK physician sample breakdown, 2002

List of Figures

Figure 1: Sample breakdown by respondent type -Stakeholder Opinions survey: FSD, 2005

Figure 2: Number of respondents per country – Stakeholder Opinions survey: FSD, 2005

Figure 3: US: treatment pathway for HSDD among the premenopausal and postmenopausal clinical population, 2005

Figure 4: US: treatment pathway for FSAD among the premenopausal and postmenopausal clinical population, 2005

Figure 5: UK: treatment pathway for HSDD among the premenopausal and postmenopausal clinical population, 2005

Figure 6: UK: treatment pathway for FSAD among the premenopausal and postmenopausal clinical population, 2005

Figure 7: Spain: treatment pathway for HSDD among the premenopausal and postmenopausal clinical population, 2005

Figure 8: Spain: treatment pathway for FSAD among the premenopausal and postmenopausal clinical population, 2005

Figure 9: Basson’s model of female sexual functioning

Figure 10: Overview of some of the key limitations of existing FSD classification systems and their implications

Figure 11: Breakdown of respondent’s female patient population by menopausal status in the US, UK, Spain and Germany/Italy/France, 2005

Figure 12: Percentage of patients experiencing some degree of sexual functioning problems in the US, UK, Spain and Germany/Italy/France, 2005

Figure 13: Breakdown of patients with sexual functioning problems by menopausal status in the US, UK, Spain and Germany/Italy/France (%), 2005

Figure 14: Prevalence of female patients experiencing more than one sexual dysfunction in the US, UK, Spain and Germany/Italy/France (%), 2005

Figure 15: Breakdown of sexual pain in premenopausal patients by pain subtype and country in the US, UK, Spain and Germany/Italy/France (%), 2005

Figure 16: Breakdown of sexual pain in postmenopausal patients by pain subtype and country in the US, UK, Spain and Germany/Italy/France (%), 2005

Figure 17: Estimated percentage of patients with sexual functioning problems who are reported to also suffer from other conditions in the US, UK and Spain, 2005

Figure 18: Summary of most significant barriers to presentation or help-seeking for sexual functioning problems among women in the US, UK, Spain and Germany/Italy/France, 2005

Figure 19: Top 10 reported symptoms or complaints presented by patients in the US and Europe, 2005

Figure 20: Percentage of respondents who conduct routine screening for sexual functioning problems by country and physician specialty, 2005

Figure 21: Percentage of female patients screened for sexual dysfunction by respondents who carry out routine screening by country, 2005

Figure 22: Percentage of patients screened for FSD by respondents, by co-morbid or associated condition in the US, UK, Spain and Germany/Italy/France, 2005

Figure 23: Summary of evaluation tools and techniques used to diagnose FSD among all respondents in the US, UK, Spain and Germany/Italy/France, 2005

Figure 24: Mean percentage of all respondents using various guidelines in the US, UK, Spain and Germany/Italy/France, 2005

Figure 25: Mean percentage of respondents reporting use of each diagnostic guideline in the US, 2005

Figure 26: Mean percentage of respondents reporting use of each diagnostic guideline in Spain, 2005

Figure 27: Mean percentage of respondents reporting use of each diagnostic guideline in the UK, 2005

Figure 28: FSD treatment options

Figure 29: Average percentage of female patients with sexual dysfunction receiving each treatment approach by region, 2005

Figure 30: Percentage of patients receiving non-drug therapy options for female sexual dysfunction by country, 2005

Figure 31: Treatment of premenopausal HSDD by therapeutic approach and country (%), 2005

Figure 32: Treatment of postmenopausal HSDD by therapeutic approach and country (%), 2005

Figure 33: Treatment of premenopausal FSAD by therapeutic approach and country (%), 2005

Figure 34: Treatment of postmenopausal FSAD by therapeutic approach and country (%), 2005